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Trial registered on ANZCTR


Registration number
ACTRN12623000470695
Ethics application status
Approved
Date submitted
21/04/2023
Date registered
8/05/2023
Date last updated
28/04/2024
Date data sharing statement initially provided
8/05/2023
Date results information initially provided
28/04/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Contouring Conformance comparing Barrigel® with Surgical Clips for Post-Lumpectomy Cavity Delineation in Breast Cancer
Scientific title
Contouring Conformance comparing Barrigel® with Surgical Clips for Post-Lumpectomy Cavity Delineation in Breast Cancer
Secondary ID [1] 309503 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breast cancer 329782 0
Condition category
Condition code
Cancer 326679 326679 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants with newly diagnosed early breast cancers planned for breast conserving surgery attend the hospital for surgery.
In the operating theatre, following wide local excision of the breast cancer, the breast surgeon injects Barrigel (Non-animal stabilised hyaluronic acid gel) in the form of drops, with the goal to mark the deep and radial margins of the excision cavity. This involves drops (approximately 0.3 – 0.5 millilitres) injected using a sterile 21-23 gauge needle, starting at the base, injected just under the pectoral fascia at 4 points of the compass, indicating the deep margin. Further 4 drops are injected approximately 1cm interval above the base plane, also at 4 points of the compass, but at 1cm into the cavity wall, into the adjacent breast tissue. This is repeated at further 1cm intervals above the previous injection plane until the skin was reached. Standard surgical clips are also placed as markers at the same time to indicate the deep, radial and superficial margins of the excision cavity (approximately 4 to 6 clips are used).
Following surgery and adequate recovery (approximately 1 to 2 months, or later if the participants undergo adjuvant chemotherapy), participants attend the radiation oncology outpatient department for CT and MRI simulation planning scans, in preparation for their adjuvant radiotherapy treatment.
For the study, the scan images are de-identified and provided to radiation oncologists and radiologist to delineate the tumour bed aided by clips on CT, and gel on MRI.
These are then further evaluated for consistency and other characteristics.
The study participants' future surveillance breast imaging is then monitored for presence of the gel and its characteristics.
Intervention code [1] 325932 0
Treatment: Devices
Intervention code [2] 326036 0
Treatment: Other
Comparator / control treatment
The tumour bed delineated on CT aided by surgical clips
Control group
Active

Outcomes
Primary outcome [1] 334547 0
Inter-observer variability of the delineated tumour bed using the overlap difference of contours using clips and CT versus gel and MRI.
Timepoint [1] 334547 0
Within approximately 6 months after the final participant has undergone their CT and MRI scans.
Secondary outcome [1] 421059 0
Composite outcome of the presence or absence of the gel and its characteristics on routine surveillance breast imaging.
Timepoint [1] 421059 0
At each annual post-op visit timepoints or when surveillance imaging are performed, for up to 2 years.
Secondary outcome [2] 421368 0
Adverse events following insertion of gel drops (eg. allergic reaction, infection, pain, bleed) graded using common terminology criteria for adverse events (CTCAE) version 5.
Timepoint [2] 421368 0
Immediately after insertion, on the day of CT / MRI scan, and up until the start of radiotherapy treatment (up to approximately 3 months post intervention, or 7 months if having chemotherapy before radiotherapy)
Secondary outcome [3] 421385 0
Observer rating of the visibility and usefulness of gel drops on the MRI scans, using a 10-point Likert scale.
Timepoint [3] 421385 0
At the time of tumour bed delineation, within approximately 6 months after the final participant has undergone their CT and MRI scans.

Eligibility
Key inclusion criteria
Female patients with clinically node negative, unifocal early breast cancer, measuring a maximum diameter of 3 centimetre (cm), planned for wide local excision (WLE) and sentinel lymph node biopsy (SLNB) were eligible for the study. The breast carcinoma could be of any grade, oestrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER-2) status.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with allergy to hyaluronic acid, contraindication to magnetic resonance imaging (MRI), or who are unsuitable for RT (eg. active pregnancy, previous ipsilateral breast RT).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
All participants receive both clips and gel, and therefore act as their own control.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
28/05/2021
Date of last participant enrolment
Anticipated
Actual
17/08/2022
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
36
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24581 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 40177 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 313694 0
Hospital
Name [1] 313694 0
Austin Health
Country [1] 313694 0
Australia
Funding source category [2] 313697 0
Commercial sector/Industry
Name [2] 313697 0
Palette Life Sciences
Country [2] 313697 0
United States of America
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Road, Heidelberg, VIC 3084
Country
Australia
Secondary sponsor category [1] 315501 0
None
Name [1] 315501 0
Address [1] 315501 0
Country [1] 315501 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312861 0
Austin Health human research ethics committee
Ethics committee address [1] 312861 0
145 Studley Road
PO Box 5555 Heidelberg
Victoria Australia 3084
Ethics committee country [1] 312861 0
Australia
Date submitted for ethics approval [1] 312861 0
Approval date [1] 312861 0
30/04/2021
Ethics approval number [1] 312861 0
HREC/68327/Austin-2020

Summary
Brief summary
This study aims to determine whether Barrigel (hyaluronic acid gel) can delineate the tumour bed after breast cancer surgery

Who is it for?
You may be eligible to join this study if you have been diagnosed with early breast cancer and planned for wide local excision (WLE) and sentinel lymph node biopsy (SLNB)

Study details
All participants in this study will have both Barrigel and standard surgical clips applied following wide local incision of the breast cancer. Approximately 4-6 weeks after surgery (or after chemotherapy if needed), participants will undergo computed tomography (CT) scans and magnetic resonance imaging (MRI) scans to visualise the gel and clip placements. A group of doctors will then independently contour out where they think the tumour bed is, and the degree of overlap of each contour will help determine its efficacy.

Participants will then be assessed annually for up to 2 years using routine surveillance breast mammography and ultrasound to determine gel presence and characteristics over the long-term.

It is hoped that this research project will provide us more information about alternative ways to improve the accuracy of post-operative radiotherapy planning and treatment in early breast cancer, especially as MRI guided planning and treatment becomes more prevalent.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126162 0
Prof Michael Chao
Address 126162 0
Department of Radiation Oncology, Austin Health, 145 Studley Road, Heidelberg, VIC 3084
Country 126162 0
Australia
Phone 126162 0
+61 3 9496 9803
Fax 126162 0
Email 126162 0
[email protected]
Contact person for public queries
Name 126163 0
Michael Chao
Address 126163 0
Department of Radiation Oncology, Austin Health, 145 Studley Road, Heidelberg, VIC 3084
Country 126163 0
Australia
Phone 126163 0
+61 3 9496 9803
Fax 126163 0
Email 126163 0
[email protected]
Contact person for scientific queries
Name 126164 0
Michael Chao
Address 126164 0
Department of Radiation Oncology, Austin Health, 145 Studley Road, Heidelberg, VIC 3084
Country 126164 0
Australia
Phone 126164 0
+61 3 9496 9803
Fax 126164 0
Email 126164 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Beginning 3 months and ending 3 years following main results publication.
Available to whom?
Researchers who provide a methodologically sound proposal, and at the discretion of the Primary Investigator.
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Yeh J, Chew G, Ng SL, Ooi WM, Loh SW, Hyett A, Lee... [More Details] 385776-(Uploaded-17-04-2024-10-29-47)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.